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Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes (PREDICTIVE™)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00655044
First Posted: April 9, 2008
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.

Condition Intervention
Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: insulin detemir

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • HbA1C [ Time Frame: after 12 weeks ]

Secondary Outcome Measures:
  • Safety [ Time Frame: during treatment ]

Enrollment: 3637
Study Start Date: May 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Type 1 and type 2 diabetes patients Drug: insulin detemir
Safety and effectiveness data collection in connection with the use of drug Levemir in daily clinical practice.
Other Names:
  • Levemir®
  • NN304

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 1 and type 2 diabetes patients
Criteria

Inclusion Criteria:

  • Type 1 diabetes
  • Type 2 diabetes
  • Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

  • Unwilling to adhere to therapy or follow up
  • Pregnancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655044


Locations
Russian Federation
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119330
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00655044     History of Changes
Other Study ID Numbers: NN304-3514
First Submitted: April 4, 2008
First Posted: April 9, 2008
Last Update Posted: October 28, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin Detemir
Hypoglycemic Agents
Physiological Effects of Drugs